Tretinoin
Altreno, Atralin, Avita, Renova, Retin-a, Solage, Tri-luma, Twyneo, Veltin, Ziana (tretinoin) is a small molecule pharmaceutical. Tretinoin was first approved as Retin-a on 1982-01-01. It is used to treat acne vulgaris, facial dermatoses, hyperpigmentation, and promyelocytic leukemia acute in the USA. The pharmaceutical is active against retinoic acid receptor alpha, retinoic acid receptor gamma, and retinoic acid receptor beta. In addition, it is known to target Nuclear receptor ROR-beta, nuclear receptor subfamily 2 group C member 2, peroxisome proliferator-activated receptor delta, nuclear receptor subfamily 2 group E member 1, and retinoic acid receptor RXR-alpha.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Altreno, Atralin, Avita, Renova, Retin-a (generic drugs available since 1998-12-24, discontinued: Vesanoid)
CombinationsTri-luma, Twyneo, Veltin, Ziana (generic drugs available since 1998-12-24, discontinued: Solage)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benzoyl peroxide
+
Tretinoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TWYNEO | Galderma | N-214902 RX | 2021-07-26 | 1 products, RLD, RS |
Clindamycin phosphate
+
Tretinoin
Fluocinolone acetonide
+
Hydroquinone
+
Tretinoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRI-LUMA | Galderma | N-021112 RX | 2002-01-18 | 1 products, RLD, RS |
Mequinol
+
Tretinoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SOLAGE | Almirall | N-020922 DISCN | 1999-12-10 | 1 products |
Hide discontinued
Tretinoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RETIN-A | Bausch Health Companies | N-019049 RX | 1988-09-16 | 1 products, RLD, RS |
| ATRALIN | Dow Pharmaceutical Sciences | N-022070 RX | 2007-07-26 | 1 products, RLD, RS |
| ALTRENO | Dow Pharmaceutical Sciences | N-209353 RX | 2018-08-23 | 1 products, RLD, RS |
| AVITA | Mylan | N-020404 RX | 1997-01-14 | 1 products |
| RETIN-A | Bausch Health Companies | N-017522 RX | 1982-01-01 | 1 products, RLD, RS |
| RETIN-A | Bausch Health Companies | N-017579 RX | 1982-01-01 | 1 products, RLD, RS |
| RETIN-A | Bausch Health Companies | N-017955 RX | 1982-01-01 | 1 products, RLD, RS |
| RETIN-A-MICRO | Bausch Health Companies | N-020475 RX | 2014-01-28 | 2 products, RLD, RS |
| RETIN-A MICRO | Bausch Health Companies | N-020475 RX | 1997-02-07 | 2 products, RLD, RS |
| RETIN-A | Bausch Health Companies | N-017340 RX | 1982-01-01 | 1 products, RLD, RS |
Show 1 marketed
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atralin | New Drug Application | 2016-07-01 |
| avita | New Drug Application | 2018-07-24 |
| renova | New Drug Application | 2019-09-30 |
| retin-a micro | New Drug Application | 2017-10-23 |
| tretinoin | ANDA | 2023-02-28 |
| tri-luma | New Drug Application | 2021-08-26 |
| twyneo | New Drug Application | 2022-03-15 |
| veltin | New Drug Application | 2021-08-01 |
| ziana | New Drug Application | 2017-03-01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BENZOYL PEROXIDE / TRETINOIN, TWYNEO, GALDERMA LABS LP | |||
| 2024-07-26 | NC | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tretinoin, Altreno, Dow Pharm | |||
| 10653656 | 2038-08-22 | DP | U-2368 |
| 11324710 | 2038-08-22 | U-2368 | |
| Benzoyl Peroxide / Tretinoin, Twyneo, Galderma Labs Lp | |||
| 10420743 | 2038-07-12 | U-3194 | |
| 10653899 | 2030-12-30 | DP | U-3194 |
| 11071878 | 2030-12-30 | DP | |
| 9868103 | 2028-08-08 | DP | U-3194 |
| 8617580 | 2028-02-03 | DP | |
| Fluocinolone Acetonide / Hydroquinone / Tretinoin, Tri-Luma, Galderma Labs Lp | |||
| 7915243 | 2023-09-08 | DP | |
| 7939516 | 2023-09-08 | DP | |
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AD: Retinoids for topical use in acne
— D10AD01: Tretinoin
— D10AD51: Tretinoin, combinations
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XF: Retinoids for cancer treatment
— L01XF01: Tretinoin
HCPCS
Code | Description |
|---|---|
| S0117 | Tretinoin, topical, 5 grams |
Clinical
Clinical Trials
247 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 8 | 3 | 4 | 16 | 3 | 34 |
| Scabies | D012532 | B86 | 1 | 3 | 7 | 1 | 2 | 14 | |
| Promyelocytic leukemia acute | D015473 | C92.4 | — | 6 | 6 | 1 | — | 13 | |
| Covid-19 | D000086382 | U07.1 | 1 | 4 | 1 | 1 | — | 7 | |
| Melanosis | D008548 | EFO_0003963 | L81.1 | 1 | 1 | 1 | 4 | 1 | 7 |
| Pediculus | D010374 | — | 1 | 1 | 1 | 3 | 6 | ||
| Lice infestations | D010373 | B85.2 | 1 | — | 4 | 1 | — | 6 | |
| Malaria | D008288 | EFO_0001068 | B54 | — | — | 1 | 1 | 2 | 4 |
| Healthy volunteers/patients | — | 2 | — | — | 1 | — | 3 | ||
| Trachoma | D014141 | A71 | — | 1 | — | 1 | — | 2 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 10 | 10 | 7 | — | — | 22 | |
| Myelodysplastic syndromes | D009190 | D46 | 9 | 9 | 2 | — | — | 15 | |
| Leukemia | D007938 | C95 | 4 | 6 | 6 | — | 1 | 15 | |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 4 | 1 | — | 1 | 6 |
| Hematologic neoplasms | D019337 | 2 | 2 | 1 | — | — | 3 | ||
| Rosacea | D012393 | L71 | — | 2 | 2 | — | — | 3 | |
| Male breast neoplasms | D018567 | — | 1 | 1 | — | — | 2 | ||
| Purpura | D011693 | HP_0000979 | D69.2 | — | — | 1 | — | — | 1 |
| Neutropenia | D009503 | D70 | — | — | 1 | — | — | 1 | |
| Lyme disease | D008193 | A69.2 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | 3 | 11 | — | — | 1 | 14 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 5 | — | — | — | 6 | |
| Multiple myeloma | D009101 | C90.0 | 2 | 2 | — | — | — | 3 | |
| Lymphoma | D008223 | C85.9 | 1 | 3 | — | — | — | 3 | |
| Melanoma | D008545 | 1 | 3 | — | — | — | 3 | ||
| Prostatic neoplasms | D011471 | C61 | 1 | 1 | — | — | — | 2 | |
| Actinic keratosis | D055623 | L57.0 | — | 1 | — | — | 1 | 2 | |
| Uterine cervical neoplasms | D002583 | — | 1 | — | — | 1 | 2 | ||
| Wilms tumor | D009396 | 1 | 2 | — | — | — | 2 | ||
| Adenoid cystic carcinoma | D003528 | — | 2 | — | — | — | 2 |
Show 25 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | — | — | — | — | 3 |
| Disease | D004194 | EFO_0000408 | R69 | 2 | — | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 |
Show 17 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tick bites | D064927 | — | — | — | — | 2 | 2 | ||
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | — | — | — | 2 | 2 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | 1 | 1 | |
| Hepatic insufficiency | D048550 | — | — | — | — | 1 | 1 | ||
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Tick-borne diseases | D017282 | — | — | — | — | 1 | 1 | ||
| Dengue | D003715 | A90 | — | — | — | — | 1 | 1 | |
| Smoking | D012907 | EFO_0003768 | F17 | — | — | — | — | 1 | 1 |
| Metabolism | D008660 | GO_0008152 | — | — | — | — | 1 | 1 | |
| Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | TRETINOIN |
| INN | tretinoin |
| Description | All-trans-retinoic acid is a retinoic acid in which all four exocyclic double bonds have E- (trans-) geometry. It has a role as a keratolytic drug, an antineoplastic agent, an antioxidant, a signalling molecule, a retinoid X receptor agonist, an anti-inflammatory agent, an AP-1 antagonist, a retinoic acid receptor agonist and a human metabolite. It is a retinoic acid and a vitamin A. It is a conjugate acid of an all-trans-retinoate. |
| Classification | Small molecule |
| Drug class | retinol derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC1=C(/C=C/C(C)=C/C=C/C(C)=C/C(=O)O)C(C)(C)CCC1 |
Target
Agency Approved
RARA
RARA
RARG
RARG
RARB
RARB
Organism
Homo sapiens
Gene name
RARA
Gene synonyms
NR1B1
NCBI Gene ID
Protein name
retinoic acid receptor alpha
Protein synonyms
Nuclear receptor subfamily 1 group B member 1, nucleophosmin-retinoic acid receptor alpha fusion protein NPM-RAR long form, PML-DDX5-RARA fusion, PML-DDX5-RARA fusion protein, RAR-alpha, retinoic acid receptor, alpha polypeptide
Uniprot ID
Mouse ortholog
Rara (19401)
retinoic acid receptor alpha (P11416)
Alternate
RORB
RORB
NR2C2
NR2C2
PPARD
PPARD
NR2E1
NR2E1
RXRA
RXRA
Organism
Homo sapiens
Gene name
RORB
Gene synonyms
NR1F2, RZRB
NCBI Gene ID
—
Protein name
Nuclear receptor ROR-beta
Protein synonyms
Nuclear receptor RZR-beta, Nuclear receptor subfamily 1 group F member 2, Retinoid-related orphan receptor-beta
Uniprot ID
Mouse ortholog
—
—
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 186,904 documents
View more details
Safety
Black-box Warning
Black-box warning for: Tretinoin
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
2,385 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more